Experts Highlight the Need for Greater Diversity in Dermatological Clinical Research

At the Skin of Color Update 2024 conference in New York City, researchers shared medical and aesthetic dermatology updates, focusing on diversity in clinical trials as well as recent drug approvals.

Image credit: Andrey Popov | stock.adobe.com

Diversity in Clinical Trials

Valeria M. Harvey, MD, MPH, FAAD, past president of the Skin of Color Society, discussed the lack of progress in increasing racial and ethnic minority participation in clinical trials over the past 3 decades, which she said has exacerbated health disparities.¹

“Diverse clinical trial representation matters because diverse cohorts contribute to a more comprehensive data set. It restores trust of potential participants who've lost confidence in the institutions and the people conducting research studies. Clinical trials provide life saving access to interventions and valuable insights to more safe and effective use of medical products for our patients,” Harvey said.¹

JAMA Dermatology has published a systematic review that analyzed diversity in 626 published randomized controlled trials. Harvey said the study found that only 60% of studies report data on race and ethnicity, with 74% of participants being White. She highlights the need for better instruments for measuring skin of color and the importance of diversity in clinical trial staff and principal investigators. However, she noted that there are multiple tools in progress that aim to correct the drawbacks and biases of the Fitzpatrick skin type scale, which is a way to classify skin based on how it reacts to sunlight exposure.¹

Harvey said on June 26, 2024, the FDA released a draft guidance on Diversity Action Plans (DAPs) that is intended to increase the number of underrepresented groups enrolled in clinical studies, aimed to improve enrollment. The DAP requires sponsors to specify rationales and goals for the study enrollment by age, ethnicity, sex, and race, while describing the methods to meet the benchmarks. Additionally, Harvey said the DAP applies to phase 3 and pivotal studies for drugs, biologics, and certain devices, applying to trials enrolling in December 2025.¹

Harvey announced Diversity Clinical Research Mentoring, which is a partnership program co-developed by the Dermatology Section of the National Medical Association and the Skin of Color Society. The program aims to cultivate the skills and expertise of the next generation of principal investigators from underrepresented groups. Harvey noted that the program consists of 3 phases: foundations, in-person training, and a longitudinal component, with mentees receiving funding and working side by side with mentors.¹

How Pharmacists Can Get Involved

Harvey said health care providers and clinicians, including pharmacists, are encouraged to get involved and grow their knowledge on the importance of inclusive marketing and ensuring that all aspects of clinical trials are diverse and inclusive. By doing this, it allows pharmacists, clinicians, and health care providers to educate the patients and the public, thereby building public trust.¹

“This is a very complicated topic, but I do believe there are things that we can do to help move this initiative along the industry. Making sure that you partner with communities from the beginning during the design part of the studies, selecting sites and diverse communities, ensuring that your investigators are diverse, and making sure that your marketing and all of everything that you do is inclusive,” Harvey said.¹

Advances in Dermatology

Andrew F. Alexis, MD, MPH, FAAD, shared recent advances in dermatology, highlighting approvals for topical therapies including roflumilast and tapinarof.

Roflumilast cream 0.15% (Zoryve; Arcutis) was approved in July for the treatment of atopic dermatitis in adults and children as young as 6 years of age. It is a once-daily, steroid-free cream shown to provide rapid disease clearance and significant itch reduction, and it has specifically been formulated for long-term use and disease control.³

Similarly, tapinarof cream 1% (Vtama; Dermavant) has been recently shown to improve itch in phase 3 trials of moderate to severe atopic dermatitis. It has demonstrated significant efficacy and is well tolerated in adults and children down to 2 years of age in the ADORING 1 and 2 identical phase 3 trials.⁴

Although dupliumab (Dupixent; Sanofi, Regeneron) and tralokinumab (Tezspire; Amgen, AstraZeneca) are currently the only 2 biologics FDA-approved for the treatment of atopic dermatitis, other biologics are undergoing clinical trials. These include secukinumab, bimekizumab, and nemolizumab.²

Following, Alexis noted that an open-label Phase 3b study assessed the safety and efficacy of lebrikizumab among adults and adolescent individuals with skin of color with moderate to severe atopic dermatitis— showing tolerable results. He said that while it is not yet FDA approved, it’s anticipated to receive an outcome by the end of this year.²

“[There are] a lot of exciting developments just over the past year and anticipated to come in the upcoming year,” Alexis said. “Our armamentarium has strengthened greatly, and we’ve been offered so much more for our patients of all skin types, especially our patients with skin of color, who have historically had so many unmet needs in terms of treatment options.”²

REFERENCES

1. Harvey V. Medical & Aesthetic Dermatology Updates, Diversity in Dermatology Clinical Trials:Where Do We Stand? Skin of Color Update 2024. Midtown, New York. Presented September 13, 2024. Accessed September 13, 2024.

2. Alexis A. Medical & Aesthetic Dermatology Updates, Recent Notable & Newsworthy DrugApprovals: What’s New in the MedicalDermatology Armamentarium for PatientsWith Skin of Color. Skin of Color Update 2024. Midtown, New York. Presented September 13, 2024. Accessed September 13, 2024.

3. FDA Approves Arcutis' Zoryve (roflumilast) Cream 0.15% for the Treatment of Atopic Dermatitis in Adults and Children Down to 6 Years of Age. News release. Arcutis Biotherapeutics.

4. Silverberg J, Boguniewicz M, Rubenstein D, Tallman A, Brown P. Tapinarof cream improved itch in two phase 3 trials of moderate to severe atopic dermatitis. Ann Allergy, Asthma, & Immunol. 2023;131(5):S90.